Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™

NCT03247829 | Completed Results

• 1 other identifier: SJM-CIP-10178
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 23

Brief Summary

This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions

Conditions

Heart Failure

Keywords

CardioMEMS; Left Ventricular Assist Device; Hemodynamic Management

Outcome Measures

Primary Outcomes (1)

• Six Minute Hall Walk (6MHW) Distance

  Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

  Six Months

Other Outcomes (8)

• Change in PA Diastolic Pressure From Baseline to 6 Months

  six months

• Days PA Diastolic Pressure is in the Pre-specified Target Range

  six months

• PA Diastolic Pressure Before 6MHW Test to After 6MHW Test

  6 months

Study Arms (2)

Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment

Patients with CardioMEMS PA Sensor and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS HF System

Device: Hemodynamic management using CardioMEMS HF System

Group B: Patients with existing HeartMate LVAD implanted with CardioMEMS PA Sensor post enrollment

Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, will receive hemodynamic management using CardioMEMS HF System

Device: Hemodynamic management using CardioMEMS HF System

Interventions

Hemodynamic management using CardioMEMS HF System DEVICE

Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges

Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment; Group B: Patients with existing HeartMate LVAD implanted with CardioMEMS PA Sensor post enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart Failure patients will be recruited from the clinicians practice based on the presence of both devices under study

You may qualify if:

• Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III symptoms, and has had a previous HF hospitalization and meets FDA indications for CardioMEMS. The CardioMEMS PA Sensor must be implanted within 72 hours of consent (Group B)
• Signed an informed consent form and agreed to provide access to patient and device data (including CardioMEMS Merlin.net data)
• No connectivity or transmission problems with CardioMEMS
• On HeartMate LVAD support for at least 3 months
• Age ≥ 18 years

You may not qualify if:

• Current participation in an investigation that is likely to confound study results or affect study outcome
• Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the two year follow-up for that trial
• Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe arthritis, orthopedic issues, amputation etc.)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (23)

Scripps Health

La Jolla, California, 92037, United States

Location

USC University Hospital

Los Angeles, California, 90033, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

San Diego Cardiac

San Diego, California, 92123, United States

Location

California Pacific Medical Center - Van Ness Campus

San Francisco, California, 94109, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

The Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27607, United States

Location

University of North Carolina

Raleigh, North Carolina, 27607, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio Sate University

Columbus, Ohio, 43210, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97225, United States

Location

Palmetto Health Richland

Columbia, South Carolina, 29203, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Aurora Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

• Thohan V, Abraham J, Burdorf A, Sulemanjee N, Jaski B, Guglin M, Pagani FD, Vidula H, Majure DT, Napier R, Heywood TJ, Cogswell R, Dirckx N, Farrar DJ, Drakos SG; INTELLECT 2-HF Investigators. Use of a Pulmonary Artery Pressure Sensor to Manage Patients With Left Ventricular Assist Devices. Circ Heart Fail. 2023 Jun;16(6):e009960. doi: 10.1161/CIRCHEARTFAILURE.122.009960. Epub 2023 Apr 20.

  PMID: 37079511 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

No limitations or caveats to disclose for this study.

Results Point of Contact

• Title: Dr. Marie-Elena Brett, PhD; Principal Scientist Clinical Research
• Organization: Abbott_Medical_Devices

marieelena.brett@abbott.com

17815283613

Study Officials

• Kartik Sundareswaran

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 14, 2017
• Study Start: August 24, 2017
• Primary Completion: March 6, 2020
• Study Completion: June 30, 2020
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)